The BME Life
The BME Life
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What is a 510k? When Do I Need One? / Medical Device Regulations
Welcome to The BME Life, your ultimate guide to navigating the complexities of medical device regulations. In this video, we dive deep into the world of 510(k) submissions-an essential topic for medical device entrepreneurs and professionals alike.
Join us as we demystify the 510(k) process, a premarket submission to the FDA ensuring a device is as safe and effective as a legally marketed predecessor (predicate device). Learn how device classification, technological characteristics, and modifications influence the need for a 510(k). Discover key components of a successful submission, from regulatory information to performance data and labeling requirements.
Key Topics Covered:
Understanding the 510(k) pathway and its regulatory framework.
Determining when your device requires a 510(k) submission.
Exploring substantial equivalence: aligning intended use and technological characteristics with predicate devices.
Overview of essential documentation for a comprehensive 510(k) submission.
Step-by-step guide to preparing, submitting, and navigating FDA review processes.
Conclusion:
Whether you're introducing a new device or modifying an existing one, knowing when to pursue a 510(k) submission is crucial for regulatory compliance and market success in the medical device industry. Stay informed, proactive, and subscribe to our channel for more expert insights on mastering medical device regulations.
Ready to navigate your device's regulatory journey? Contact us today for expert guidance tailored to your specific needs. Don't forget to like, comment, and subscribe for future updates on FDA regulations and medical device innovations.
Переглядів: 76

Відео

Understanding Regulatory Pathways in the Medical Device Industry | Expert Insights
Переглядів 114Місяць тому
Welcome to TheBMELife, your premier destination for expert insights into regulatory strategies in the medical device industry. In this informative video, we dive deep into the crucial topic of regulatory pathways: what they are, when to create them, and how they influence the journey from product development to market approval. Timestamps: Introduction to Regulatory Pathways Early Planning and ...
Negotiating Salary and Promotions as Women in STEM - Kristen Mittal from Mittal Consulting
Переглядів 601Рік тому
Hello everyone and welcome to The BME Life! In this BME Life Podcast episode, Kristen Mittal from Mittal Consulting talks to us about negotiating salary and promotions as women in STEM. She shares some tips on how to negotiate a higher salary, when to take no for an answer, how to set yourself up for a promotion during your next evaluation, the importance of women in STEM negotiating higher sal...
Startup Spotlight - Jessica Bussert, Wave Therapeutics (EP2)
Переглядів 362Рік тому
In today's Startup Spotlight we'll be hearing from Jessica Bussert, CEO/President/Founder at Wave Therapeutics. Wave Therapeutics, has developed the first smart cushioning technology designed to prevent bedsores, save lives, and reduce a huge cost center for long-term and acute care facilities. Jessica talks to us about her company and technology, as well as her journey thus far as an entrepren...
Day in My Life as a Sales Engineer
Переглядів 18 тис.Рік тому
Learn what the day in the life of working as a sales engineer looks like! Don't forget to SUBSCRIBE! 00:00 Intro - Day In The Life Working as a Sales Engineer (Hardware Systems) 02:15 What does a SE do? 08:26 What about BME? 13:43 Visiting a Client 14:59 Outro In this video, I'll be walking you through my day working as a sales engineer selling hardware solutions. We're going to be discussing w...
Tech Review - Muse S Headband for Meditation and Sleep
Переглядів 1 тис.Рік тому
Hello BME Life family! Today we have a very exciting tech review video featuring the Muse S Brain Sensing Headband. Muse can be used to track your sleep and meditation practices, meaning that it helps you refocus during the day and recover overnight, which is something I know we all need. I was very excited to try Muse because I’ve always been someone who gets easily stressed. Especially these ...
Startup Spotlight - Richard Ricci, Co-Founder of CubeClick (EP 1)
Переглядів 5132 роки тому
We are kicking off our Startup Spotlight series with Dr. Richard Ricci from CubeClick. CubeClick is a medical device startup developing a SaMD (software as a medical device) product for dental x-ray imaging. In this interview, Dr. Ricci shares with us about the legalities of founding a startup. We talk about patents, trademarks, contracts, FDA submissions and more! Below are some resources that...
DEDAKJ Oxygen Concentrator - Tech Review
Переглядів 12 тис.2 роки тому
Hi everyone and welcome to The BME Life! Today we will be reviewing DEDAKJ's oxygen concentrator. This device takes pure water and converts it in oxygen. The flow rate is adjustable, making the purity of oxygen delivered adjustable as well (the higher the flow, lower purity level and viceversa). Pure oxygen therapy in general is good for sleep, reducing stress levels, etc. But it is mostly reco...
Biomedical Engineering Salaries - How Much Can You Earn?
Переглядів 12 тис.2 роки тому
Hello aspring Biomedical Engineers! We have one of our most desired videos here. We constantly get the question, "What can I expect to earn as a Biomedical Engineer?" The truth is, that that answer can vary depending on where you are, what company you work for, and what your role is. So we did the impossible! We created a survey that we personally sent to BME's in the workforce, however, their ...
Ingenieria Biomedica - Entrevista con Estudiante de Preparatoria (Spanish Video)
Переглядів 5192 роки тому
Hello everyone! This is a video recording of a meeting I had with a high school student to answer some questions they had about BME. She is in her senior year in a high school in Mexico, and is interested in pursuing BME in Canada. We talked about the different fields of BME, ways for high school students to get exposure to BME, challenges in BME, my professional experience in BME, how BMEs int...
Answering questions about BME! - Interview with Sci Ninja
Переглядів 8883 роки тому
Answering questions about BME! - Interview with Sci Ninja
How Much Do Biomedical Engineers Make? / Biomedical Engineering Salary
Переглядів 14 тис.3 роки тому
How Much Do Biomedical Engineers Make? / Biomedical Engineering Salary
Biomedical Engineering Day in the Life / Medical Device Startup, Regulatory Affairs
Переглядів 11 тис.3 роки тому
Biomedical Engineering Day in the Life / Medical Device Startup, Regulatory Affairs
Ingeniería Biomédica Q&A - Mi Experiencia
Переглядів 2 тис.3 роки тому
Ingeniería Biomédica Q&A - Mi Experiencia
Should YOU study Biomedical Engineering? What is Biomedical Engineering?
Переглядів 250 тис.3 роки тому
Should YOU study Biomedical Engineering? What is Biomedical Engineering?
Day in the Life of a Biomedical Engineer
Переглядів 2,9 тис.3 роки тому
Day in the Life of a Biomedical Engineer
Meet Stryker! // Salaries, Career Opportunities & Biomedical Engineering Products
Переглядів 18 тис.3 роки тому
Meet Stryker! // Salaries, Career Opportunities & Biomedical Engineering Products
What is the Difference Between Bioengineering and Biomedical Engineering?
Переглядів 108 тис.3 роки тому
What is the Difference Between Bioengineering and Biomedical Engineering?
Senior Design for Engineering Students // Biomedical Engineering
Переглядів 2,9 тис.3 роки тому
Senior Design for Engineering Students // Biomedical Engineering
TECH REVIEW - Blood Pressure Monitoring Watch
Переглядів 78 тис.3 роки тому
TECH REVIEW - Blood Pressure Monitoring Watch
REACTION TO: ''The Story of Why I QUIT Biomedical Engineering in College"
Переглядів 26 тис.3 роки тому
REACTION TO: ''The Story of Why I QUIT Biomedical Engineering in College"
Medical Device Regulations / FDA Approval
Переглядів 32 тис.4 роки тому
Medical Device Regulations / FDA Approval
My Advice to BME College Students
Переглядів 10 тис.4 роки тому
My Advice to BME College Students
Product Development 101 // Medical Device Startup Guide
Переглядів 9 тис.4 роки тому
Product Development 101 // Medical Device Startup Guide
Let's Have a Conversation About the Current Pandemic // How It Has Been Affecting Me
Переглядів 3804 роки тому
Let's Have a Conversation About the Current Pandemic // How It Has Been Affecting Me
The Make-A-Thon Story
Переглядів 9614 роки тому
The Make-A-Thon Story
Day in the Life of a Biomedical Engineering Student // Quarantine Vlog
Переглядів 3,7 тис.4 роки тому
Day in the Life of a Biomedical Engineering Student // Quarantine Vlog
500 Subscriber SPECIAL!! Thank YOU!
Переглядів 1444 роки тому
500 Subscriber SPECIAL!! Thank YOU!
Medical Device Marketing Pitch / BME Senior Design
Переглядів 1,6 тис.4 роки тому
Medical Device Marketing Pitch / BME Senior Design
BME Senior Design Project // Ambulatory Fetal Monitoring System (Prototype Demo)
Переглядів 7 тис.4 роки тому
BME Senior Design Project // Ambulatory Fetal Monitoring System (Prototype Demo)

КОМЕНТАРІ

  • @fernandoalonsoromero7365
    @fernandoalonsoromero7365 5 днів тому

    Hey guys, just suscribed to your channel. I was looking for some videos showing how is life for medtronic field service engineers in other countries and came up with your video. I´m a field service enginner for Medtronic working in Mexico. I´m responsible for CST technology, O-arm and neuronavigation. I´m glad I found this podcast guys, I started as a biomedical engineer working at hospitals, I will check more of your videos.

  • @Selly123-p1n
    @Selly123-p1n 8 днів тому

    Am I not able to do a bio medical engineering degree if Im studying maths,physics n ict without biology and chemistry in my high school

  • @poggermon2893
    @poggermon2893 18 днів тому

    What is the bachelors course to take to get into bme

  • @Stormfly56
    @Stormfly56 20 днів тому

    I would like to become a biomedical engineer so that I can be able to improve medical health facilities in the country. So that one day I can be able to save millions of lives

  • @MouniksBodigam
    @MouniksBodigam 22 дні тому

    Thank you for providing the information. It is simple, accurate, covered almost all necessary points..

  • @mohdnihalcs
    @mohdnihalcs 25 днів тому

    Mam, is biomedical Engineering and medical engineering the same ? I mean in some countries there is no biomedical engineering course but medical engineering course is available….in internet medical engineering is just another name for biomedical engineering in some countries….iam looking to study abroad so i have a confusion about the course….pls reply

  • @sidhantmishra9875
    @sidhantmishra9875 28 днів тому

    Could please provide link for list of devices which are exempted from 510k submission

  • @dianeyev7536
    @dianeyev7536 28 днів тому

    Vivo en EEUU también y llevo meses buscando un canal como este, gracias

    • @TheBMELife
      @TheBMELife 28 днів тому

      Que padre! Estamos a tu servicio 🤗

  • @Rodios-k9e
    @Rodios-k9e 29 днів тому

    I am a btech graduate in civil engineering Is it possible for me to do a master's in biomedical engineering?

  • @shaziafirasat9926
    @shaziafirasat9926 Місяць тому

    how to check if which Lasers are approved in Canada

  • @mohdnihalcs
    @mohdnihalcs Місяць тому

    Is biomedical engineering same as medical engineering…also will doing medical physics be a advantage for this ?

  • @reallymusa_
    @reallymusa_ Місяць тому

    Graduated with a first now I am the first person in my class looking for different jobs

  • @Aaradhya.Amrutkar
    @Aaradhya.Amrutkar Місяць тому

    HI i am a student currently in 11 from india can you please tell me some collages in india about this fantastic field

  • @slz1119
    @slz1119 Місяць тому

    Hi, madam, if I want to market a class I medical device, do I need to submit any dossier to the FDA?

    • @TheBMELife
      @TheBMELife Місяць тому

      It depends! Some Class I devices do require 510(k) submissions.

  • @LycheeSlayer
    @LycheeSlayer Місяць тому

    Not me an art major trying to convince myself into getting a BME ms 😭

    • @TheBMELife
      @TheBMELife Місяць тому

      Why not?! 😄 you’d be surprised but a lot of engineers are very artistic!

  • @vikaspaygude1600
    @vikaspaygude1600 Місяць тому

    Please makes video on how to take admission to BMEor BioE out sides India other universities 🙏🙏🙏

  • @vikaspaygude1600
    @vikaspaygude1600 Місяць тому

    Thank you so much 🙏🙏👌👌

  • @sarfarazmohammed8376
    @sarfarazmohammed8376 2 місяці тому

    Bme is a very unworthy job in India Believe me I am working as a bme in a hospital. The nursing staff will not respect you , the doctors won't respect you and u ll be paid very very less

  • @collinsssentamu2601
    @collinsssentamu2601 2 місяці тому

    Do I need to be good at biology before taking on this degree

  • @ChiefThundermoon
    @ChiefThundermoon 2 місяці тому

    what i aksed is what does it do to our food?

  • @user-tq4ll6uz1s
    @user-tq4ll6uz1s 2 місяці тому

    Can you help me please

  • @viky007veera
    @viky007veera 2 місяці тому

    Simple and effective 👌🏻

  • @maulik...2380
    @maulik...2380 2 місяці тому

    Lots of love for posting this information

  • @SamInNZ
    @SamInNZ 2 місяці тому

    Does the app need to be left open while sleeping?

  • @tuyishimemichelraphael1625
    @tuyishimemichelraphael1625 3 місяці тому

    I really appreciate you 🙏

  • @viru5472
    @viru5472 3 місяці тому

    Which domain is urs in engineering. What is theRoad path to become sale's engineering

  • @JamesConley-fc6it
    @JamesConley-fc6it 3 місяці тому

    Very interesting and nessery in more patients especially for military patients

  • @JamesConley-fc6it
    @JamesConley-fc6it 3 місяці тому

    I have metel brackets with microw screws around my right eye. So yes I'm very interested

  • @rajanpramod
    @rajanpramod 3 місяці тому

    Can a mbbs doctor become biomedical engineer

  • @chinnasamyk5160
    @chinnasamyk5160 3 місяці тому

    Thank you for this video it is so helpful for me mam😊

    • @chinnasamyk5160
      @chinnasamyk5160 3 місяці тому

      I was not good in physics what can I do

  • @Me.655
    @Me.655 3 місяці тому

    The denominator is supposed to be the value of the monitor rather than that of the watch, right? btw! I super love this video! It is so encouraging* to see that a young bme knows how to apply the things you have learned in bme to your life and world problems and that of others! Makes me want to do that too! Btw! the mistake I mentioned is really just a question cause I am not super used to the formula I just googled it rn

  • @Me.655
    @Me.655 3 місяці тому

    how did you find a sponsor?

  • @GhettoSuguru
    @GhettoSuguru 3 місяці тому

    Hi its been 4 years how are you doing now ?

    • @TheBMELife
      @TheBMELife Місяць тому

      I’m doing great! I’m a regulatory specialist in the medical device field

  • @SKRaj-pl2oi
    @SKRaj-pl2oi 3 місяці тому

    I am inspired by this video and going take up BME in Bachelor's

  • @funnyturtles8954
    @funnyturtles8954 4 місяці тому

    I'm studying computer science and i want to transfer into medical robotics. would choosing comp sci + bio med eng be the right choice to get into medical robotics?

  • @eskanor8572
    @eskanor8572 4 місяці тому

    Not me planning to study biomedical engineering 💀 But the thing is Am very good at biology by understanding biology not by memorising, in fact I enjoy understanding and learning biology so if You can memories it's not a problem in my opinion it's just you have to study differently

  • @Alchemist_171
    @Alchemist_171 4 місяці тому

    Still waiting for more content

    • @TheBMELife
      @TheBMELife Місяць тому

      More coming soon! Check our latest video we just uploaded today :)

  • @alejandrocelery3091
    @alejandrocelery3091 4 місяці тому

    The t-shirt is way too cute!

  • @psingh007
    @psingh007 4 місяці тому

    Biomedical engg is atleast 4 decades old

  • @intiruiz1161
    @intiruiz1161 4 місяці тому

    I’m from Kalamazoo. It’s cal-la-ma-zoo

  • @biomedico4273
    @biomedico4273 5 місяців тому

    Hii Biomedical why you are not uploading videos

    • @TheBMELife
      @TheBMELife Місяць тому

      Check out our latest video uploaded today!

  • @siddi47
    @siddi47 5 місяців тому

    See when you put it like that, you have me a lot more excited.

  • @Alfaruq107
    @Alfaruq107 5 місяців тому

    Wow!! I can't thank you enough for adding to my passion for this area

    • @TheBMELife
      @TheBMELife Місяць тому

      Happy to hear that! 😄

  • @chiamakauzoma311
    @chiamakauzoma311 5 місяців тому

    I have interest in tech and I also love biology I also have a nack for innovation and entrepreneurship so I think this is the course for me

  • @Daddykb
    @Daddykb 5 місяців тому

    I hate this, so now what do I choose

  • @timcao6801
    @timcao6801 5 місяців тому

    Heres the main problem of BME as a major: you dont need a degree in BME to do BME. BME companies will hire MechE, EE, and BME. But if you want to go into ME/EE, it might be harder to convince them that you have the necessary depth of knowledge because you likely won't have it in the first place.

  • @user-ms8yn6oi7e
    @user-ms8yn6oi7e 5 місяців тому

    Hi Mam please can you help me my name is MOSAROF I'm from Bangladesh I'm 35 year old I'm suffering MND ALS disses one year please can you help me

  • @YYYKING
    @YYYKING 5 місяців тому

    I have a quesiton right now am in my 11th grade but at my school in A levels you only pick three subjects to continue with now i picked PCB ( physics, chemistry and biology) so am wondering if it would be possible to do BME at university if i only did PCB at my A levels with math included

  • @arulmani8132
    @arulmani8132 6 місяців тому

    Happy to watch the video of your career experiences 🤗

  • @arulmani8132
    @arulmani8132 6 місяців тому

    Thank you for good session.